Testicular Tissue Cryopreservation for Fertility Preservation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
AgeNot listed
SponsorUniversity of Pittsburgh
About this trial
Testicular tissue cryopreservation is an experimental procedure where a young boy's testicular tissue is retrieved and frozen. This technique is reserved for young male patients who are not yet producing mature sperm, with the ultimate goal that their tissue may be used in the future to restore fertility when experimental techniques emerge from the research pipeline.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Be male at any age.
Be scheduled to undergo surgery, chemotherapy, drug treatment and/or radiation for the treatment or prevention of a medical condition or malignancy with risk of causing permanent and complete loss of subsequent testicular function.
Or, have a medical condition or malignancy that requires removal of all or part of one or both testicles.
Have newly diagnosed or recurrent disease. Those who were not enrolled at the time of initial diagnosis (i.e., patients with recurrent disease) are eligible if they have not previously received therapy that is viewed as likely to result in complete and permanent loss of testicular function.
Disqualifiers
Diagnosed with psychological, psychiatric, or other conditions which prevent giving fully informed consent.
Diagnosed with an underlying medical condition that significantly increases their risk of complications from anesthesia and surgery.
Trial design
Design model
Single group
Treatments tested in this trial
Testicular biopsy
Procedure/SurgeryTesticular biopsy is performed to obtain testicular tissue for cryopreservation
Treatment groups
1,500 Participants
are divided into 1 treatment groupGroup A: Testicular tissue biopsyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Presence of spermatogonial stem cells in the testicular tissue as determined by histology.
A segment of testicular specimen (\~5%) will be removed and assessed for presence of spermatogonial stem cells by immunofluorescence and hematoxylin staining
Time frame
5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pittsburgh
Lead sponsor
Medical College of Wisconsin
Collaborator
University of Chicago
Collaborator
Helen DeVos Children's Hospital
Collaborator
Seattle Children's Hospital
Collaborator
Source ClinicalTrials.gov